With high rates of multiple sclerosis, Canada has an obligation to be aggressive in determining whether a controversial new treatment for multiple sclerosis works. Newfoundland and Labrador took a creative and eye-opening step when it announced on Monday that its scientists will assess patients before and after the treatment.
By announcing an "observational study" of MS patients from Newfoundland who have received the treatment abroad, the province is opening itself up to accusations that it is encouraging people to try an unproven, perhaps even dangerous or "quack" treatment.
In an ideal world, the province would accept for the study only those patients who are enrolled in clinical treatment studies elsewhere. The problem is that such clinical studies are uncommon. And if patients were enrolled in clinical studies, there would be no need for the observational study.
This is the chicken-and-egg question that this country's 75,000 multiple sclerosis patients are up against. The treatment, which involves the dilation of blocked veins with balloon catheters, is unproven. To prove its value would require clinical studies that apparently cannot be done because the treatment is unproven.
A panel set up by the Canadian Institutes of Health Research has rejected studies at this time. It was highly skeptical of Dr. Zamboni's theory of vein abnormalities in MS patients, and went so far as to say the studies probably would not receive approval from hospital ethics boards because of the risk of harm from the treatment. One day later, federal Health Minister Leona Aglukkaq said no to clinical trials. Most provinces, except Saskatchewan, which intends to pay for trials in the province, and Newfoundland, seem prepared to follow suit.
But another approach is possible. The State University of New York at Buffalo received ethics approval to establish the safety of the treatment in a 10-patient "lead-in trial" in June. "We had absolutely no issues whatsoever," Nick Hopkins, the chairman of the neurosurgery department, said on Monday. The university will soon enroll 20 patients in a preliminary treatment study. Only those who have been identified in imaging tests as having vein abnormalities will be candidates. The university previously did a study that found those blockages more common in MS patients than in those who do not have MS. (A similar study is being done in Hamilton.)
Canadian health ministers should consider a question posed by Dr. Hopkins: "If you say, 'We're not going to study it,' how are you ever going to learn?" Newfoundland and Labrador's answer is to be innovative and willing to go out on a limb in looking for the truth.
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